BEUDAMED
    FDA Adverse Event Death Summary report: N

    VALIANT

    MDR report key: 3217231 · Received July 10, 2013

    Report

    Report Number
    2953200-2013-01318
    Event Type
    Death
    Date Received
    July 10, 2013
    Date of Event
    January 23, 2013
    Report Date
    June 13, 2013
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: PRE-OPERATIVE DISSECTION OF THORACIC AORTA. RENAL FAILURE, CVA, PARALYSIS, RESPIRATORY FAILURE, PROXIMAL TYPE I ENDOLEAK, TYPE II ENDOLEAK, DEATH, ISCHEMIA REPERFUSION INJURY, RESPIRATORY FAILURE, RESPIRATORY INFECTION, RENAL FAILURE, INTESTINAL TRACK NECROSIS, ENCEPHALOPATHY, MULTIPLE ORGAN FAILURE, ADULT RESPIRATORY DISTRESS SYNDROME, HEPATIC FAILURE, HYDROPERICARDIUM, PLEURAL EFFUSION, INTESTINAL INFECTION, ISCHEMIC PANCREATITIS, SYSTEMIC INFLAMMATORY RESPONSE SYNDROME. INSUFFICIENT INFORMATION; CAUSE IS UNKNOWN. CONCLUSIONS: PRE-OPERATIVE DISSECTION OF THORACIC AORTA. RENAL FAILURE, CVA, PARALYSIS, RESPIRATORY FAILURE, PROXIMAL TYPE I ENDOLEAK, TYPE II ENDOLEAK, DEATH, ISCHEMIA REPERFUSION INJURY, RESPIRATORY FAILURE, RESPIRATORY INFECTION, RENAL FAILURE, INTESTINAL TRACK NECROSIS, ENCEPHALOPATHY, MULTIPLE ORGAN FAILURE, ADULT RESPIRATORY DISTRESS SYNDROME, HEPATIC FAILURE, HYDROPERICARDIUM, PLEURAL EFFUSION, INTESTINAL INFECTION, ISCHEMIC PANCREATITIS, SYSTEMIC INFLAMMATORY RESPONSE SYNDROME. INSUFFICIENT INFORMATION; CAUSE IS UNKNOWN.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS OBTAINED FROM A JOURNAL ARTICLE. EARLY MALPERFUSION, ISCHEMIA REPERFUSION INJURY, AND RESPIRATORY FAILURE IN ACUTE COMPLICATED TYPE B AORTIC DISSECTION AFTER THORACIC ENDOVASCULAR REPAIR. JIANG XIONG, MINHONG ZHANG, WEI GUO*, XIAOPING LIU, TAI YIN, XIN JIA, HONGPENG ZHANG, YONGLE XU AND LIJUN WANG. (JOURNAL OF CARDIOTHORACIC SURGERY 2013; 8:17). DOI:10.1186/1749-8090-8-17 BACKGROUND: THE AIM OF THIS STUDY WAS TO DETERMINE THE EARLY MORTALITY AND MAJOR COMPLICATIONS OF ACUTE COMPLICATED TYPE B AORTIC DISSECTION (ACBD) AFTER THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR). METHODS: TWENTY-SIX CONSECUTIVE PATIENTS WITH ACBD WHO UNDERWENT TEVAR WERE INCLUDED. CLINICAL INDICATIONS BEFORE TEVAR AND IN-HOSPITAL MORTALITY AND MAJOR COMPLICATIONS AFTER TEVAR WERE ANALYZED AND COMPARED WITH SIMILAR REPORTS. RESULTS: TEVAR WAS TECHNICALLY SUCCESSFUL IN ALL CASES. IN-HOSPITAL MORTALITY OCCURRED IN FOUR PATIENTS (15%), AND MAJOR COMPLICATIONS OCCURRED IN AN ADDITIONAL FOUR PATIENTS (15%). THREE OF THE FOUR (75%) OF THE DEATHS WERE ASSOCIATED WITH MALPERFUSION AND ISCHEMIA REPERFUSION INJURY (IRI), AND 3/4 (75%) OF THE MAJOR COMPLICATIONS WERE CAUSED BY RESPIRATORY FAILURE (RF). CONCLUSIONS: IN-HOSPITAL MORTALITY ASSOCIATED STRONGLY WITH SEVERE END-ORGAN MALPERFUSION AND IRI, WHILE MAJOR COMPLICATIONS ASSOCIATED WITH RF, DURING TEVAR. OUR RESULTS INDICATE THAT MALPERFUSION, IRI AND RESPIRATORY FAILURE DURING TEVAR SHOULD BE CAREFULLY MONITORED AND AGGRESSIVELY TREATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316449 VALIANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR Death| R